Ignite Creation Date:
2024-05-05 @ 9:21 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00866242
Status:
TERMINATED
Last Update Posted:
2021-04-29
First Post:
2009-03-19
Brief Title:
Safety and Efficacy Challenge Study of CVD 1208S a Live Attenuated Oral Vaccine to Prevent Shigella Phase IIb
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Safety Immunogenicity and Efficacy Following Experimental Challenge of CVD 1208S a Delta guaBA Delta Sen Delta Set Shigella Flexneri 2a Live Oral Vaccine Phase IIb Challenge Study
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reactogenicity met study halting criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether CVD 1208S a live attenuated oral vaccine is safe and effective in the prevention of Shigella infection
Detailed Description:
The study comprises a Phase 2 vaccination study and a Phase 2b challenge study The primary objectives of the Phase 2 vaccination study are 1 To evaluate in healthy volunteers the safety and clinical acceptability of three spaced doses one month apart of an investigational live oral attenuated vaccine called CVD 1208S with particular attention to the occurence of diarrhea dysentery and fever and 2 To characterize immune responses following ingestion of this vaccine The primary objective of the Phase 2b challenge study is to measure the protective efficacy of 3 spaced doses of vaccine after ingestion of an oral challenge strain called Shigella flexneri 2a strain 2457T
Shigella is a leading cause of disease and death among children younger than 5 years living in developing countries The difficulty controlling this infection has led experts to believe that prevention with the use of a vaccine is a promising strategy At the CVD we have pursued an approach of developing an oral attenuated Shigella vaccine that prevents infection with the Shigella types of greatest clinical and epidemiologic importance One of the strains to be included in the vaccine is called Shigella flexneri 2a Investigators at the CVD have created a vaccine from Shigella flexneri 2a designated CVD 1208S using molecular biology techniques To date nearly 40 subjects have received varying doses of this vaccine with good clinical tolerance and modest immunogenicity Previously a single dose of vaccine was used In the current study we will administer doses of vaccine on days 0 28 and 56 to attempt to maximize immunogenicity Approximately one month after the 3rd dose a group of 15-20 vaccinated volunteers along with a similar number of unvaccinated control subjects will be admitted to the CVD Research Isolation Ward at SNBL and challenged with wild type Shigella flexneri 2a By comparing the attack rate of illness in vaccinated vs unvaccinated subjects we will determine the vaccines ability to confer protective immunity
Shigella is a leading cause of disease and death among children younger than 5 years living in developing countries The difficulty controlling this infection has led experts to believe that prevention with the use of a vaccine is a promising strategy At the CVD we have pursued an approach of developing an oral attenuated Shigella vaccine that prevents infection with the Shigella types of greatest clinical and epidemiologic importance One of the strains to be included in the vaccine is called Shigella flexneri 2a Investigators at the CVD have created a vaccine from Shigella flexneri 2a designated CVD 1208S using molecular biology techniques To date nearly 40 subjects have received varying doses of this vaccine with good clinical tolerance and modest immunogenicity Previously a single dose of vaccine was used In the current study we will administer doses of vaccine on days 0 28 and 56 to attempt to maximize immunogenicity Approximately one month after the 3rd dose a group of 15-20 vaccinated volunteers along with a similar number of unvaccinated control subjects will be admitted to the CVD Research Isolation Ward at SNBL and challenged with wild type Shigella flexneri 2a By comparing the attack rate of illness in vaccinated vs unvaccinated subjects we will determine the vaccines ability to confer protective immunity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Shigella CVD 27000 | OTHER | University of Maryland Center for Vaccine Development | None |